Regarding Approval of Epidiolex

An important message from National Hemp Association Chairman Geoff Whaling

REGARDING FDA APPROVAL OF EPIDIOLEX

Yesterday, as long anticipated, the Food and Drug Administration (FDA) approved GW Pharmaceutical’s Epidiolex, a cannabidiol (CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy. Please see FDA’s press release here, and this statement from the FDA’s Commissioner.

Personally, I am challenged with this development, as providing access to CBD for families and specifically for children suffering from Dravet Syndrome is what brought me to the hemp industry.

The hemp industry has been waiting on this FDA development with nervous anticipation. Some in the industry feared the worst – that the retail sale of hemp-derived CBD would be made illegal. It has not – yet there is much more work to be done.

The National Hemp Association, through our affiliation with the US Hemp Roundtable, has reviewed the release with its FDA counsel, Amin Talati Upadhye (ATU). Here are our preliminary conclusions:

Fundamentally, Epidiolex’s approval has no legal impact on the sale of hemp derived CBD.

The FDA instead focuses its concern on the “proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.” The FDA notes that its recent Warning Letters have been aimed at companies that make such “unproven medical claims.” The Roundtable applauds the FDA’s efforts to target bad actors in the industry who undermine legitimate hemp-derived products by making unproven claims, and we look forward to working with federal and state agency officials through our continuing effort to develop standards, best practices and self-regulation for the industry.

The FDA Commissioner’s comments reference “marijuana” and not the essential oil extracted from the hemp crop. CBD from hemp has been legally authorized, under certain conditions and state permits, via the 2014 Farm Bill. Yet we too know that the DEA does not see a difference between Hemp and Marijuana and consider extract from both a controlled substance.

Further, in ATU’s opinion, the arguments related to the marketing of hemp-derived CBD as a dietary supplement remain the same as before FDA’s approval of Epidiolex. That is, ATU believes there is proof of marketing of hemp-derived CBD as a food or dietary supplement prior to the institution of substantial clinical investigation that was made public by GW Pharmaceuticals. Even if FDA’s argument — that the relevant IND preclusion date should be the date in which it authorized the article for investigation as a drug (roughly January 4, 2006) — were to be adjudicated and upheld in Court, there is proof of marketing of hemp-derived CBD as a food or dietary supplement even prior to January 4, 2006.Given that the FDA’s approval of Epidiolex raises the visibility of CBD products, it is even more critical that Congress passes the Hemp Farming Act to permanently establish hemp and hemp-derived products as agricultural commodities, removing them from the purview of the Controlled Substances Act. We encourage supporters of hemp and hemp-derived CBD to contact their Congressmen today to urge them to support passage of the 2018 Farm Bill AND the Hemp Farming Act of 2018.